The following Structured Product Label (SPL) was submitted to the FDA by H And P Industries, Inc. Dba Triad Group for the product Triadine (NDC 50730-8308). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not, ask a doctor in case of, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredient
Povidone Iodine USP 7.5% w/v (equivalent to 0.75% titratable iodine)
Purpose
Uses
- Surgical hand scrub for health care processionals
- Health Care Antiseptic for preparation of the skin prior to surgery
- First Aid Antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns
Warnings
Do Not
- use in the eyes
- apply over large areas of the body
- use on individuals who are allergic or sensitive to iodine
- use as a first aid antiseptic for longer than 1 week unless directed by a doctor
Ask A Doctor In Case Of
- deep or puncture wounds
- animal bites
- serious burns
Otc - Ask Doctor/Pharmacist
Otc - When Using
Stop Use And Ask A Doctor
- if condition persists for more than 72 hours
- if irritation and redness develop
Otc - Pregnancy Or Breast Feeding
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
As a surgical hand scrub for use by health care professionals- clean under nails with a nail pick
- nails should be maintained with 1 millimeter free edge
- wet hands and forearms
- apply milliliter (teaspoon) or palmful to hands and forearms
- scrub thoroughly paying particular attention to nails, cuticles and interdigital spaces
- rinse and repeat scrub
For preparation of the skin prior to surgery- clean the affected area
- apply to the operative site prior to surgery
As a first aid antiseptic
- clean the affected area
- apply a small amount of this product to the area 1-3 times daily
- may be covered with a sterile bandage
- if bandaged, let dry first
Other
Store at room temperature 15° - 30° C (59° - 86° F)
Inactive Ingredients
Citric acid, glycerin, nonoxynol-9, PEG-300, sodium hydroxide, sodium phosphate, water
Otc - Questions
TriadCat. No. 10-8308NDC 50730-8308-3scrubPOVIDONE IODINESOLUTION, USP7.5% Povidone Iodine (0.75% titratable iodine)Antiseptic / GermicideAntiseptic for preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infectionFirst aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burnsFor hospital and professional use onlyTriad Disposables, Inc.
Brookfield, WI 53045 USA8 fl. oz.(236 ml)
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